Safety and Risk Information

Indication for Use

The LifeStream™ Balloon Expandable Vascular Covered Stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries.

Contraindications

The LifeStream™ Balloon Expandable Vascular Covered Stent is contraindicated for use in:• Patients with uncorrected bleeding disorders• Patients who cannot receive recommended antiplatelet and/or anticoagulation therapy• Patients who are judged to have a lesion that prevents full expansion of the implant• Lesions in which the lumen diameter post balloon angioplasty is insufficient for the passage of the endovascular system• Lesion locations subject to external compression.

Warnings

The LifeStream™ Balloon Expandable Vascular Covered Stent is supplied sterile and is intended for single use only. Do not resterilize and/or reuse the device. Reuse, resterilization, reprocessing and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or injury, illness or death of the patient.• Patients with allergies or hypersensitivity to stainless steel or ePTFE may suffer an allergic response to this implant.• Do not use if packaging/pouch is damaged. Use the device prior to the USE BY date specified on the package.• Stenting across a vessel side branch may impede blood flow and hinder or prevent future procedures.• Stenting into a bifurcation may compromise future diagnostic or therapeutic procedures.• Should excessive resistance be felt at any time during the insertion process, do not force passage.• Attempts to retract the covered stent into the sheath/guiding catheter may result in dislodgement and embolization of the covered stent. Maintain guidewire placement across the lesion and withdraw the endovascular system only until the proximal end of the covered stent is aligned with the tip of the sheath/guiding catheter. Do not attempt to remove an unexpanded covered stent through the sheath/guiding catheter. Remove the sheath/guiding catheter and endovascular system as a single unit. Attempting to remove an unexpanded covered stent by pulling it back into the sheath/guiding catheter may result in stent dislodgement.• Do not exceed the maximum rated burst pressure since this increases the potential for balloon rupture and vessel damage. The use of a pressure monitoring device is recommended to prevent over pressurization.• Use only diluted contrast medium for balloon inflation. Do not use air or any gaseous medium to inflate the balloon as this may cause uneven expansion and difficulty in deployment of the covered stent. For the contrast/saline solution, a ratio of 50/50 is recommended.• The covered stent cannot be repositioned after it is deployed.• Do not retract the balloon until the balloon is fully deflated under vacuum.• Confirm optimal covered stent wall apposition using standard angiographic techniques. If the covered stent has not achieved full wall apposition, a post dilation with an appropriately sized balloon should be performed. 5-8 mm devices may be post-dilated with balloons up to 10 mm in diameter. 9-12 mm devices may be post-dilated with balloons up to 12 mm in diameter.• Do not expose the covered stent to temperatures higher than 500 °F(260 °C). ePTFE decomposes at elevated temperatures, producing highly toxic decomposition products.• Use of a laser on or around the surface of the covered stent may result in damage to the covered stent and could create toxic fumes, which may harm the patient or operator.• After use, the delivery system is a potential biohazard. Handle and dispose of it in accordance with accepted medical practice and applicable local, state and federal laws and regulations.

Precautions

The device should only be used by physicians who are trained in endovascular procedures and are familiar with the complications, side effects and hazards of peripheral vascular interventions.• Anatomical variances may complicate the procedure; use caution when advancing the endovascular system through tortuous or difficult anatomy.• Prior to device use, refer to the Covered Stent Sizing Table on the label and read the Instructions for Use.• Do not use if the delivery system cannot be properly flushed.• Crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage.• This device has not been tested for use in overlapped conditions with stents or covered stents from other manufacturers.• Store in a cool and dry place. Keep away from sunlight.

Potential Adverse Events

Potential patient/device adverse effects that may occur include, but are not limited to, the following:• Abscess• Allergic / anaphylactoid reaction• Amputation• Aneurysm / pseudoaneurysm• Angina/coronary ischemia• Arterial occlusion/thrombus, near the puncture site• Arterial occlusion/thrombus, remote from puncture site • Arterial occlusion / restenosis of the treated vessel• Arteriovenous fistula• Arrhythmia• Balloon rupture• Blockage of major collateral artery or arterial branch• Bypass surgery• Covered stent dislodgement from balloon during tracking procedure• Covered stent misplacement during placement procedure• Covered stent migration post placement procedure• Covered stent insufficient wall apposition• Covered stent deformation / kink / fracture• Death• Distal embolization• Drug reaction or allergic reaction to medication, substances or materials used for the procedure (e.g. anticoagulation or antiplatelet agent, contrast medium, stent or catheter materials)• Edema• Fever• Hemorrhage/bleeding• Hematoma and/or bleeding at puncture (access) site• Hypotension / hypertension• Inability to introduce/withdraw endovascular system• Inability to track endovascular system to the target lesion• Inability to inflate the balloon/deploy covered stent• Infection at access site• Infection at or around implant• Inflammation• Ischemia / infarction of tissue/organ• Malposition / Malapposition• Myocardial infarction• Pain• Radiation injuries• Renal insufficiency / failure/toxicity• Respiratory arrest• Restenosis in the treatment area / covered stent edge• Sepsis• Shock• Stroke/Transient Ischemic Attack (TIA)• Thromboembolic event / thrombosis• Vasospasm• Vessel wall trauma, perforation / dissection / rupture

Please consult the package insert for more detailed safety information and instructions for use.

BD-82096